Vietnam MOH registration 240000170/PCBB-HN
The IVD (In Vitro Diagnostic) reference equipment cluster and control material of Biorex Diagnostics Ltd
VN: Cụm trang thiết bị y tế IVD chất hiệu chuẩn, vật liệu kiểm soát của hãng Biorex Diagnostics Ltd
Vietnam·Risk Class TTBYT Loại B·Theo theo phụ lục·Biorex Diagnostics Ltd·Registered Jan 23, 2024Registration details
- Analysis ID
- 240000170/PCBB-HN
- Submission ID
- 000.00.19.H26-240117-0020
- Product Type
- Theo theo phụ lục
- Product Code
- Theo phụ lục
Company information
- Manufacturer
- Biorex Diagnostics Ltd
- Manufacturer Country
- Theo theo phụ lục
- Product Owner
- Biorex Diagnostics Ltd
- Authorized Representative
- CÔNG TY CỔ PHẦN SƠN MÀI VIỆT
Technical details
- Intended Use
- - The HbA1c Calibrator Series is designed to calibrate quantitative HbA1c tests; - The HbA1c Control Set is designed to assess the accuracy and precision of the HbA1c analyte; - Calibration Serum is a calibrator serum used to calibrate clinical chemistry tests on multiple types of automated analyzers; - Human Assayed Control is a dried human serum control material with two levels (normal and high) used in the laboratory. It will be used to monitor the accuracy of the Calibration, Electrolyte, and Enzyme processes.
Dates and status
- Registration Date
- Jan 23, 2024
About this record
Access comprehensive regulatory information for The IVD (In Vitro Diagnostic) reference equipment cluster and control material of Biorex Diagnostics Ltd in Vietnam's medical device market through Pure Global AI's free database. This Risk Class TTBYT Loại B medical device is registered under number 240000170/PCBB-HN and manufactured by Biorex Diagnostics Ltd. The authorized representative in Vietnam is CÔNG TY CỔ PHẦN SƠN MÀI VIỆT.
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